Symfony Plus has Received FDA Approval.

Posted , 7 users are following.

this is a symfony with a near add or perhaps a trifocal. Shannon Wong just mentioned it on Youtube and it is also listed on FDA approval as of 5/1.

this lens was also mentioned to me by dr. safran from new jersey. but that was a couple of months before the panoptix was approved.

1 like, 21 replies

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  • Posted

    Hi RonAKA. What was the title of the Shannon Wong video? Googling the IOL I find clinical trial info that sites a 2021 completion date. Can you point to the source of the FDA approval? Thanks.

    • Posted

      RonAKA is a different person.

      for fda approval you can search for

      p980040s109

  • Posted

    DeviceTECNIS Symfony PLUS Extended Range Of Vision Intraocular Lens (IOL), Model ZHR00, TECNIS Symfony PLUS Extended Range Of

    Generic NameExtended Depth Of Focus Intraocular Lens

    Regulation Number886.3600

    Applicant

    Johnson & Johnson Surgical Vision, Inc.

    1700 E. St. Andrew Place

    Santa Ana, CA 92705

    PMA NumberP980040

    Supplement NumberS109

    Date Received11/06/2019

    Decision Date05/01/2020

    Product Code POE

    Advisory CommitteeOphthalmic

    Supplement TypeNormal 180 Day Track

    Supplement ReasonChange Design/Components/Specifications/Material

    Expedited Review Granted?No

    Combination Product No

    Approval Order Statement

    modification of the optics to elongate the depth of focus further than the optical parent lens, the TECNIS Symfony

  • Posted

    Thanks for the tip, Soks! Wonder how much greater DOF this has over older Symfony and if they have toned down the nighttime issues. Seems like this would be the more logical choice over Panoptix if you already have a Symfony. Wonder how this got approved before Eyhance too but maybe this is a better option now.

  • Edited

    Not much buzz on Symfony Plus. It's not surprising it got FDA approval quickly as it is just a modification of an existing FDA approved lens. But at the same time, I guess the question is how much of an improvement does it really provide, or is this J&J protecting US market share against PanOptix until J&J gets their tri-focal approved in the US.

    One article... search for "In the Pipeline CRSToday" for article from April this year.

    Apparently, the Symfony Plus now adds a "violet light blocker".

    The doctor writes this about Symfony Plus: "Time will tell whether Tecnis Symfony Plus achieves the same distance acuity benchmark and thus replaces Tecnis Symfony in our practice or whether the two end up being complementary, either in a personalized mix-and-match scenario or through patient selection."

    The article also highlights (earlier in the story) two IOLs in development that sound like they have promise.

    • Alcon Vivity, which is available in some European markets now,
    • FineVision Triumf, which combines tri-focal with EDOF
    • Posted

      that's a great article. vivity appears to be very promising. no rings and vision upto 66cm is so tempting.

      it makes 2 references to near improvement: a) 1 line improvement and b) large improvement.

      would be nice to see the defocus curve.

      what is the difference between blue light filter and UV filter.? tecnic optiblue is the blue light that makes it yellow.

    • Posted

      UV filter is standard in every IOL now.

      Some manufacturers (including Alcon in the PanOptix lens I have)have added a blue filter as they believe based on animal studies blue filter helps protect the retina, and may help prevent macular degeneration. But there is a debate on the pros and cons.

      Seems like violet light filter (which Symfony Plus has) is the latest develop on the blue filter trend -- providing some retinal protection.

    • Posted

      does that filter make it yellow like the synergy? yellow tecnis iols are suffixed with a V. ZHR00V would be yellow symfony plus.

    • Posted

      In my long post about my PanOptix experience from 9 months ago (it's on page 2 now), I did not notice any major difference in color in the week between my Right eye (which had the more severe cataract) and my left eye surgery.

      My comment was (copying from my old post):

      The PanOptix lens has both a UV filter (this is standard) and a blue light filter (several manufacturers have added this as they think it may help reduce risk of macular disease, while some other manufacturers don’t believe blue filter is beneficial). I compared the colors I see with my new Right eye (which has the IOL) with my left eye (still natural lens but with cataracts). I don’t notice any perceptible difference in color, except when looking at my wood deck is pressure treated wood with a semi-transparent still. With my left eye (natural lens with cataract), the wood has a more yellowish hue compared to my Right eye (IOL with blue filter), but difference is not major.

      Now they say cataract will make colors more yellowish, so the difference could be due to the cataract in my natural eye. But other than looking at pressure treated wood, I did not notice any difference in color. I've also read articles about experience of visual artists with blue filter IOL, and I don't recall anyone commenting on difference in color perception.

      From sounds of it, violet filter should have even less impact on colors than blue filter.

      I believe whatever filter manufacturers use, they are not getting too much into the visible light spectrum.

  • Posted

    vivity also got fda approved in february so should be available soon in US

    i think it may not have that good intermediate as only 37% have 20/25 or better for intermediate vision per FDA website.

  • Posted

    image

    • Posted

      Hi soks. What is the source of the image? I'm finding very little on the Google about Plus.

    • Posted

      google image search. there is an article by Ashley McEvoy for Leading in Eye Health

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